REDCap eConsent Templates Now Available for Use in Human Research
The VCU Human Research Protection Program and the C. Kenneth and Dianne Wright Center for Clinical and Translational Research are pleased to announce that REDCap eConsent templates are now available for use in human research.
Full IRB guidance on the use of REDCap eConsent will be available under the “Informed Consent” accordion on the VCU HRPP’s Policies and Guidance webpage. Below is a synopsis of the guidance.
The REDCap eConsent templates provide for both delivery of consent information and collection of legally valid signatures from participants, as well as the workflow for obtaining all signatures required on a consent form per regulation/VCU policy. REDCap eConsent templates can also support interactive elements that enhance participant engagement with and comprehension of consent information, such as hover-over text definitions, multimedia components, and comprehension check questions.
When can REDCap’s eConsent templates be used?
REDCap eConsent templates can be used for non-FDA-regulated research in the United States that requires the collection of signatures. REDCap eConsent templates can be used when the consent discussion or study happen entirely remotely; can be used in-person to enhance the consent discussion; or can be used in some hybrid manner.
FDA-regulated research can not use REDCap’s eConsent templates, and instead must use Part 11 DocuSign, due to specific requirements for signatures for FDA-regulated research. Studies wishing to obtain signatures from foreign participants should also use DocuSign, which can meet the signature requirements of other countries.
REDCap eConsent templates also can not be used to obtain assent signatures from children or decisionally-impaired adults. Studies involving assent procedures must obtain approval for a verbal assent process, or must obtain physical assent signatures.
Investigators wishing to use the REDCap eConsent templates with Limited English Proficiency (LEP) individuals are strongly encouraged to consult with the IRB prior to proposing the use of the REDCap eConsent template for their study.
The VCU IRB has developed a comparison chart that illustrates the differences between REDCap eConsent and DocuSign.
Why might someone want to use REDCap’s eConsent templates?
Some studies may take place entirely remotely, but still require signatures, so a mechanism for obtaining legally-valid signatures is desirable. In some studies, an LAR or a child’s second parent may not be able to physically be present at the research site, so a mechanism for remotely obtaining signatures is more convenient for participants. Some studies may wish to maintain only electronic documentation, in which case, an eConsent process is desirable. Additionally, investigators may wish to take advantage of the REDCap eConsent template’s interactive elements, in order to enhance and/or guage participant comprehension of consent information.
What are the processes involved in using REDCap’s eConsent templates?
The IRB must approve both the use of REDCap eConsent AND the resultant consent information presented to the participant. Thus, using REDCap’s eConsent templates will require a two-step IRB process, similar to the process used for translated consent documents:
- Investigators will submit the text of the consent document (typically in WORD format), the REDCap eConsent template to be used, and information about the proposed eConsent process (e.g. timing, location) to the VCU IRB and secure approval of the text and the process PRIOR to initiating REDCap eConsent development.
- Investigators will then use the VCU IRB approved consent language and the REDCap eConsent template to develop the eConsent materials and process. A VCU IRB amendment must then be submitted to provide the finalized eConsent template and process to the IRB for approval. This second round will include using a worksheet to describe any customization of the eConsent template used by the study team, and to provide any interactive elements used in the eConsent template.
Investigators are strongly encouraged to consult with the REDCap team to customize the REDCap eConsent template for their study. Investigators can request such assistance by using the BIC request form. Select the first option in the request form for REDCap assistance, and then select “yes” to the question about eConsent support.
The VCU IRB has made available the following guidance documents for investigators to help them understand the REDCap eConsent templates, and the IRB processes related to obtaining approval to use the templates.
These guidance documents will be posted to the HRPP’s Policies and Guidance page, under the “Informed Consent” accordion.
The worksheet required to be provided in the second step of obtaining IRB approval for using REDCap’s eConsent templates is below, but will also be posted to the HRPP’s section of the OVPRI Forms webpage.
What is the difference between REDCap eConsent templates and the REDCap eConsent framework? What if I am using the framework but not the templates?
REDCap does include an “eConsent framework” that allows for collection of signatures. However, this native framework does not include the necessary identity verification required to collect legally-valid signatures. The REDCap eConsent templates, on the other hand, were developed by the VCU REDCap team and include the workflows required for identity verification, which is necessary to collect legally-valid signatures.
If you are using the native REDCap eConsent framework currently WITHOUT having a waiver of documentation of consent and/or waiver of HIPAA authorization signatures approved by the IRB, you must amend your IRB submission by June 30, 2021 to replace the use of the native REDCap eConsent framework with one of the following:
- REDCap eConsent templates
- Another eConsent platform, such as DocuSign (whether Part 11 compliant or not, as appropriate)
- A waiver of documentation of consent and/or a partial HIPAA waiver to waive the signature requirement for HIPAA authorization (applicable to minimal risk research only)
Studies currently using the native REDCap eConsent framework without using the full REDCap eConsent template, who submit a VCU IRB amendment to correct this, will NOT be subject to a finding of noncompliance for using the native REDCap eConsent framework.
However, such studies must submit an amendment to change their consent process in one of the above ways by June 30th, 2021. Studies which do not submit an amendment by that compliance date may be subject to a finding of noncompliance, as a result of a not submitting the requested VCU IRB amendment by the compliance date.
What should I do if I’m interested in using the new REDCap eConsent template’s interactive elements?
The VCU HRPP and the Wright Center are very interested in working with researchers wanting to use the REDCap eConsent template’s interactive features. If you are interested in the interactive elements of REDCap’s eConsent templates, in particular, please reach out to the REDCap team, using the BIC request form. Select the first option in the request form for REDCap assistance, and then select “yes” to the question about eConsent support.